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Indian govt to aid phase 3 trials of Russia’s covid vaccine
The government is willing to facilitate a phase 3 trial for Russia’s Sputnik V vaccine for which 2-4 Indian companies are in discussions to mass manufacture, NITI Aayog member (health) V.K. Paul said on Tuesday.
“The outreach has been extended to several companies in India, and 2-4 of them have already come forward. Others are in discussion with the Russian counterparts and the government is facilitating that process. Yes, there would be a need for a phase 3 trial in normal course of things, and if that is required, we are paving way that such a phase 3 trial, or bridging studies, as required per science and India’s regulatory system, would be facilitated by the government,” Paul said.
The Indian vaccine manufacturers are in talks with Russia’s Gamaleya National Research Center of Epidemiology and Microbiology for mass manufacturing of the ‘Sputnik V’ vaccine, which was the world’s first registered covid-19 vaccine.
However, as the phase 3 trials for the vaccine have not been completed, the Indian firm who will manufacture the vaccine may have to conduct the study in India, Paul said.
Russia’s recently approved covid-19 vaccine, Sputnik V, appears to be safe without any serious adverse effects, and developed long-term antibody response in humans during phase 1 and 2 clinical trials among 76 subjects, according to preliminary results published in The Lancet journal last week.
The government has also mapped manufacturing capacities of various vaccine makers and expects Serum Institute of India to produce 75-100 million doses per month of covid-19 vaccines.
“We have done mapped what the potential capacities are, but it is changing dynamically because there are at least 7-8 other companies, who if they get an offer or if they have their own vaccine, they will also get into the picture,” Paul said at a press conference on Tuesday.
Paul, as the chairman of the National Expert Committee on Vaccine Administration, has held discussions with five manufacturers–Serum Institute, Zydus Cadila, Bharat Biotech International, Biological E and Gennova Biopharmaceuticals—about capacities, manufacturing timelines, procurement and financing.
Serum Institute, the world’s largest vaccine manufacturer by volume, has said it will produce around 1 billion doses of the covid-19 vaccine jointly developed by the University of Oxford and Astrazeneca plc. The Pune-based firm is currently conducting a 1,600-participanyt phase 3 clinical trial of the vaccine across 17 hospitals in India.
Bharat Biotech International Ltd has also started the second phase of clinical trials of its covid-19 vaccine Covaxin, while Zydus Cadila’s phase 2 study is underway, Paul said.
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